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  AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

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  LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

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  RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

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  MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Essential Functions

• Closely monitor commercial production, implementation and execution.
• Ensure that production schedules are met, and products are manufactured according to current Good Manufacturing Practice guidelines.
• Provide technical input to batch records and other quality documents according to ICH and FDA guidelines.
• Review master and executed batch production records to ensure completeness, accuracy, and compliance with established procedures and specifications.
• Closely works with CDMO`s in setting up and maintaining operational capabilities to maximize reliability of production.
• Monitor and work closely with the CDMO`s for manufacturing deviation investigations and ensure effective CAPA implementation.
• Identify, recommend, develop and implement necessary changes, to improve quality and productivity.
• Assist in resource planning across programs to ensure adequate resources are available, escalate and resolve issues.
• Permanently ensure manufacturing operations are running efficiently and that all level of manufacturing personnel at the CDMO`s are appropriately trained and qualified to perform work assigned.
• Document and monitor key performance indicators, regularly highlighting progress, risks, and mitigation options.
• Ensure that manufacturing equipment is properly maintained, calibrated, and qualified to guarantee consistent and reliable operation.
• Work closely with Quality Control and Supply Chain to ensure that raw materials, intermediate products, and finished pharmaceutical products meet quality standards and specifications.
• Support tracking of planned and scheduled manufacturing activities at CDMOs to optimize resource utilization
• Ensure compliance with regulatory requirements, including GMP, safety and environmental regulations, and other relevant guidelines.

Requirements:

• Ph D in Biological science (Biotechnology, Biochemistry), or MS Degree/Bachelor in Biochemical Engineering.
• 8+ years of professional management experience in GMP manufacturing and external manufacturing organizations.
• Excellent team player with outstanding communication skills and a collaborative and supportive manner.
• Demonstrated ability to work effectively at all levels of a manufacturing organization.
• Proven hands-on experience in a facility start-up and commercialization environment.
• Strong organizational, teamwork, interpersonal skills, and professionalism required.
• Demonstrated hands-on experience for setting up compliant manufacturing facilities, processes, and systems.
• Proven experience in operating at Large Molecule GMP manufacturing facilities, microbial manufacturing experience desirable.
• Relentless focus and passion around process quality and improvements (efficiency and automation).
• Experience managing and adhering to budgets.
• Ability to balance, prioritize, and resolve conflicts.
• Manage multiple projects in a fast-paced environment.